Consultation on amending UK medical devices regulations

Although Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR) are in operation in the EU, medical devices legislation in Great Britain is still aligned with the former Directives for active implantable medical devices, medical devices and in vitro diagnostic medical devices.  

The Medicines and Medical Devices Act 2021 allows changes in the regulations for medical devices in order to protect public safety and so should take the safety of medical devices into account. The availability of medical devices should also be weighed up, as should the odds of the UK being deemed as a promising place to do research on medical devices, in addition to development, manufacture and supply of medical devices. 

The Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation exercise to get feedback on possible changes, with the view of updating the UK regulations on placing medical devices on the UK market, from all stakeholders. It closed on 25 November 2021 and covered topics like the scope of the regulations, conformity assessment processes, post-market surveillance, vigilance and market surveillance, re-manufacture of single use devices and registration und UDI among many other important subjects. 

It is thought that the new regulatory system will be brought in at the beginning of July 2023

It is thought that the new regulatory system will be brought in at the beginning of July 2023 when the UK is scheduled to stop accepting CE marking for medical devices in Great Britain and will use the UKCA mark. Although Northern Ireland is part of the United Kingdom, the EU MDR was implemented there in May this year and the EU IVDR will take effect there from 26 May 2022. This consultation exercise outlines proposals for a future UK-wide regime to regulate medical devices which should proceed parallel with any existing or future EU rules in keeping with the Northern Ireland Protocol.

Source: bsi 

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